
In the Harvesting Session the workshop moderators of the event will summarize the results of their discussions and highlight key findings from the World Cafés.
After studying electrical engineering Martin Fusek's career started as a project engineer and later as a project manager and quality manager for MES at Propack Data GmbH. In 2005, he moved from the vendor to customer site and hold various IT management positions within Merckle Biotech and later in the Novartis group. In 2019 he took the role of Global Program Manager Manufacturing at Merck KGaA, before he joined Roche in 2021 as Head of Manufacturing IT.
Senior Manager OT, Elevatebio
Isabelle Sumera has been with ElevateBio for 5+ years where she holds the position as Senior Manager Commercial Readiness, Business System. She currently supports data mapping and process mapping with the goal of understanding the current state of processes, identifying compliance gaps, and highlighting opportunities for improvement. In her previous roles, she leveraged 8+ years of MES experience to lead the MES and LIMS teams and support the greater OT team when implementing and maintaining GxP systems.
The Pop in Your Job: I like learning about what other people do and seeing the big picture - how everyone's work fits together and impacts each other. It makes it easy to see where systems can help them do their work more efficiently and effectively.
Senior Manager OT, Elevatebio
Isabelle Sumera has been with ElevateBio for 5+ years where she holds the position as Senior Manager Commercial Readiness, Business System. She currently supports data mapping and process mapping with the goal of understanding the current state of processes, identifying compliance gaps, and highlighting opportunities for improvement. In her previous roles, she leveraged 8+ years of MES experience to lead the MES and LIMS teams and support the greater OT team when implementing and maintaining GxP systems.
The Pop in Your Job: I like learning about what other people do and seeing the big picture - how everyone's work fits together and impacts each other. It makes it easy to see where systems can help them do their work more efficiently and effectively.
CEO & Co-founder, Apprentice.io
Co-founder & CEO of Apprentice.io – the life science industry’s first cloud-based, intelligent technology company that helps pharma manufacturers get medicine to patients faster. Through one platform Apprentice helps turn molecules into medicine, accelerating high-quality production of drugs for diseases of all types - from COVID to cancer.
Account Manager, Rockwell Automation
Sesethu Dowiasch brings with her more than 15 years of hands-on experience in automation and digitalization covering Southern Africa, Europe, and USA. In her current role, she helps Life Science manufacturers transform their manufacturing operations to bring innovative treatments to patients faster, while improving quality, yield, and product security. Her practical background in automation and mechatronics engineering gives her a unique perspective on the impact of converging IT and OT through a scalable digital transformation journey. In addition to the strategy development for process control systems and secure network architecture design, Sesethu also supports manufacturers with the vertical and horizontal integration between systems such as Batch, DCS, MES, Historian, IOT, ERP, Cloud, etc. Sesethu also serves as the Co-Chair for the ISPE Women In Pharma community of practice in the DACH region.
Global QA Manager IT Projects, Bayer AG
With over 20 years of experience in pharmaceutical manufacturing, IT systems, and quality assurance, Allelalih has driven digital transformation and regulatory compliance at Bayer and beyond.
As Global QA Manager for IT Projects at Bayer (Schweiz) AG, Allelalih oversees MES, Historian, and BES systems, developing lean validation strategies and ensuring compliance with global standards like FDA and WHO. Previously, he led Data Integrity initiatives at Bayer de México, managing IT infrastructure and streamlining validation processes for consistent global compliance.
Through roles in validation and engineering, Allelalih has consistently bridged technical solutions with business needs, enhancing manufacturing, quality, and engineering processes.
Head of Global MES Competence Team, Bayer AG
Jallaleddin is an experienced leader in Manufacturing Execution Systems (MES), currently serving as the Head of the Global MES Competence Team at Bayer. He leads a team of 14 technical experts and oversees the MES project at Bayer's most advanced production facility.
Senior Product Manager, Haleon
Karol is a highly skilled engineer with a strong technical background and extensive hands-on experience. A graduate of Poznan University of Technology, he majored in Control Engineering and Robotics and further expanded his expertise through postgraduate studies in Integrated Information Systems and Project Management.
With valuable experience gained from project teams across the globe, Karol has developed a diverse skill set backed by professional training and certifications. His expertise spans Project Management, MES Systems, Databases, PLCs, SCADA, and HMI systems, making him a versatile and knowledgeable professional in the field.
Section Lead System Analyst and Solution Configurations, Roche Pharma
With over 17 years of experience in IT operations within mission-critical manufacturing environments, Ho specializes in large-scale IT project implementation, global operational support, and regional rollouts. He has successfully led over 10 IT manufacturing application deployments across the US, Europe, and Asia. His expertise spans pharmaceutical, automotive, solar, semiconductor, and electronics manufacturing, with deep knowledge of IT service management (ITIL), GxP environments, and computer systems validation (CSV). Backed by five years of IT management experience, Ho excels in optimizing IT infrastructure, ensuring seamless operations, and driving digital transformation in highly regulated industries.
People Manager for MES IT Emerging Technologies, Novo Nordisk
Thomas is an experienced project and people manager specializing in Manufacturing Execution Systems (MES IT) and process optimization. With a strong background in overseeing supply chain operations and managing external suppliers, he excels in improving production processes within the pharmaceutical industry. Skilled in developing KPIs, facilitating continuous improvement, and implementing tools like PowerBI, Thomas drives operational efficiency while ensuring compliance with industry standards. His expertise includes managing cross-functional teams and leading strategic and technical projects to optimize manufacturing performance.
Advanced MES analyst, Novo Nordisk
1999-2004 Novo Nordisk, QC-lab Laboratory technician, Chemical and biological analysis
2004-2007 Novo Nordisk, Supporter Formulation of insulin products
2007-2010 Novo Nordisk, Special technician, Formulation of insulin products
2011-2012 Novo Nordisk, Special technician, Project coordinator, work package owner for formulation of insulin products
2012-2018 Novo Nordisk, Professional (formulation) Project manager, work package owner for formulation of hGH and hemophilia products.
2018- Novo Nordisk, Advanced MES analyst (PAS-X) in Global Novo Nordisk MES agile program.
Currently part of the Fill & Finish expansions project with focus on standardized and harmonized GMBRs for multiple site deployment.
MES analyst, Novo Nordisk
Marianne Hansen worked for Novo Nordisk for 7 years initially as Filling Process supporter and Local PAS-X super user and designer. From 2021 as Advanced MES analyst in Global Novo Nordisk MES agile program. currently part of the central PAS-X CORE 3.3. project with focus on migration and deployment.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit http://www.roche.com.
ElevateBio is a technology-driven company built to power the development of transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built state-of-the-art facilities, and integrated diverse technology platforms, including gene editing, induced pluripotent stem cells (iPSCs), and protein, vector, and cellular engineering, necessary to drive innovation and commercialization of cellular and genetic medicines. In addition, ElevateBio BaseCamp is a purpose-built, technology-enabled manufacturing platform offering process innovation, process sciences, and current Good Manufacturing Practice (cGMP) manufacturing capabilities for viral vectors, RNA, and cell therapy production. Through BaseCamp, its expanding footprint, and its next-generation enabling technologies, ElevateBio is rapidly growing its collaborations with industry partners while also selectively developing its own portfolio of cellular and genetic medicines. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare.
Apprentice.io delivers the life science industry’s only intelligent software platform built to help teams scale faster - from COVID to cancer. From small/large molecule to cell and gene therapy, Apprentice’s cloud-based system leverages artificial intelligence, augmented reality and Pharma 4.0 principles to increase an organization’s speed to market. Run your entire batch campaign and leverage your data for continuous process improvement while taking your existing procedures and making them smart. Optimize your entire supply chain, performing predictive consumable and raw material management, smart equipment tracking and preventive maintenance scheduling. Elevate your teams’ potential using language-independent, global collaboration tools in or out of the lab and suite to increase speed to resolution and decrease travel. Apprentice takes an end-to-end approach to manufacturing so you can scale faster with greater flexibility on a system that’s ergonomic and intuitive, not outdated, cumbersome or complicated. From batch execution to global collaboration, Apprentice helps manufacturing teams deliver lifesaving drugs to market faster, for the people who need them the most. Learn more at www.apprentice.io
Rockwell Automation is the largest company in the world that is dedicated to industrial automation and information. Across the globe, our flagship Allen‑Bradley® and FactoryTalk® product brands are recognized for excellence. Our keen focus on technology innovation, domain expertise, and integrity and corporate responsibility fuels our success.
Bayer is a global enterprise with core competencies in the life science fields of healthcare and nutrition. We design our products and services to serve the most essential human needs of health and nutrition. At the same time, we strive to address some of the world’s biggest challenges presented by a growing and aging global population. At Bayer, we’re committed to driving sustainable development and generate a positive impact with our businesses. Through the power of science, we’re pioneering new possibilities that advance life for all of us. That means reimagining how we care for ourselves and one another by empowering everyday health, improving approaches to patient care, and finding better ways to nourish our communities around the world.
You have loved and trusted our brands for over 170 years. We have a clear purpose, to deliver better everyday health with humanity. 💚 Our category-leading brands include Sensodyne, Panadol, Centrum, TUMS, Advil, Otrivin and Voltaren. We combine deep human understanding and trusted science to make everyday health more inclusive, more achievable and more sustainable.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 66,000 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.